This Funding Opportunity Announcement (FOA) invites applications
that seek to apply one or more innovative methodologies in communication
research across the cancer control continuum, from prevention, early
detection, diagnosis, treatment, and survivorship, to end of life.
Applications to this FOA should utilize one or more of the following analytic
approaches, methods, and data sources, including but not limited to social
media data mining, Natural Language Processing (NLP) techniques, online
social network analysis, crowdsourcing research tools (e.g., mTurk), online
search data, Ecological Momentary Assessment, neuroscience and biobehavioral
approaches to communication, and geographic information systems. Studies
should assess outcomes related to cancer prevention and control (e.g.,
knowledge, attitudes, beliefs, perceived risk, decision making in screening
and treatment, information inequalities, social support, shared decision
making, persuasion, caregiving, behavioral intentions, preventive behaviors,
and policy support, among others).

Key Dates

Posted Date

May 10, 2016

Open Date (Earliest Submission Date)

September 11, 2016

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

October 11, 2016; June 13, 2017; October 11, 2017; June
13, 2018; October 11, 2018, June 13, 2019 , by 5:00 PM local time of applicant
organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February 2017; October 2017; February 2018; October 2018; February
2019; October 2019

Advisory Council Review

New Dates May 2017; January 2018; May 2018; January 2019; May 2019; January 2020

Earliest Start Date

New Dates July 2017; April 2018; July 2018; April 2019; July 2019; April 2020

Expiration Date

New Date January 24, 2018 per issuance of NOT-CA-18-040. (Original Expiration Date: June 14, 2019)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in this
FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You must use one of these submission
options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online.

This Funding Opportunity Announcement (FOA) invites
applications that seek to apply one or more innovative methodologies in
communication research across the cancer control continuum, from prevention,
early detection, diagnosis, treatment, and survivorship, to end of life.
Applications to this FOA should utilize one or more of the following analytic
approaches, methods, and data sources, including but not limited to social
media data mining, Natural Language Processing (NLP) techniques, online social network
analysis, crowdsourcing research tools (e.g., mTurk), online search data,
Ecological Momentary Assessment, neuroscience and biobehavioral approaches to
communication, and geographic information systems. Studies should assess
outcomes related to cancer prevention and control (e.g., knowledge, attitudes,
beliefs, perceived risk, decision making in screening and treatment,
information inequalities, social support, shared decision making, persuasion,
caregiving, behavioral intentions, preventive behaviors, and policy support,
among others).

This FOA will utilize the Research Project Grant (R01)
mechanism, and is suitable for projects where proof-of-principle of the
proposed technology or methodology has already been established and supportive preliminary
data are available. This FOA runs in parallel with an FOA of identical
scientific scope, PAR-16-248,
which utilizes the Exploratory/Developmental Grant (R21) mechanism.

Background

The New Communication Landscape: The
cancer communication landscape is rapidly changing, as characterized by a rapid
diffusion of mobile technologies, Internet penetration, online communities,
social media, wikis, and a host of other participative channels. These changes
have dramatically altered the way we conceptualize and carry out health
communication research, including the way we approach intervention
development, media effects research, dissemination research, and real-time
monitoring of public discourse related to cancer, individual health behavior,
and population health. The new landscape also offers many new levers for
intervention that must be informed by updated conceptual models and new sources
of empirical data. New conceptual models are especially needed to accommodate a
shift from the traditional communication platforms of the previous decades to
the always-on, ubiquitous support platforms prevalent in the new media
landscape. Likewise, new empirical methods are needed to integrate and synthesize
the digital traces made available in the new media landscape, from passive
sensors in mobile and wearable devices, to online discourse in social media
channels, to the integrated measurement of patient outcomes recorded through
patient portals. The “hypodermic needle” communication approach, characterized
by delivering, diffusing, and disseminating information from a central source
to individuals, patient groups, communities, or the general public at the
receiving end, has shifted toward multi-directional, participative discourse,
whereby individuals and communities are exposed to and participate actively in
communication about topics relevant to cancer control. This paradigm shift
necessitates the development of research agendas that align with the changing,
participative media landscape. There is a pressing need to consider a new set
of research questions, sampling strategies, measurement techniques, and
conceptual frameworks to ensure the continued relevance and adaptation of
communication research to address critical behavioral targets across the cancer
control continuum.

Since 2000, computerized methods for data collection have
become integral to public health research, with Internet-based and mobile
platforms being used for health surveys, and increased mining of electronic
medical record (EMR) data and personal health record (PHR) data used for
collecting both objective and self-reported data points. However, these
approaches provide only a partial account of a person’s or patient’s experience,
without taking into account the larger social context (e.g., family, friends,
community networks) and the public information environment to which individuals
are exposed and from which they receive and create health-related information.
Recognizing this limitation, investigators have suggested that data from
non-traditional domains, such as mobile apps, social media, and online forums,
will provide a more complete view of individual- and population-level exposures
and trends. These participative communication technologies enable users to
interact and collaborate to generate content and data, in contrast to more
traditional communication endeavors (e.g., health education campaigns, videos,
static Web sites, and text message systems) where users passively consume
content.

Addressing Communication Inequalities and Disparities: The growth of new media offers unique opportunities to address communication
inequalities and the digital divide as they relate to cancer health
disparities. Several studies have suggested that racial and ethnic minorities
and underserved groups are using social media and mobile platforms at the same
rate as their White counterparts – thus reversing traditional notions of the
digital divide. On the other hand, there remain socioeconomic, geographic
(rural/urban) and other disparities that predict access to, trust in, and
differential use of online health communication channels, and those disparities
warrant further investigation.

Communication Surveillance: The new
communication landscape also offers unique opportunities for public health and
communication surveillance efforts. The terms “infodemiology” and
“infoveillance,” coined in 2009, describe large-scale monitoring and data
mining in public health and health communication efforts. Iterative
development is needed to improve the precision of estimates and to determine
the utility of these data for surveillance and prediction in public health
generally and cancer control specifically. To date, none of these efforts have
been cancer-specific, with the exception of small studies that have used Web
analytics to gauge public interest in a few cancer-related topics, and some
examples of how big data can be leveraged to inform surveillance techniques for
sun safety and tobacco control. Investment is needed to determine whether these
approaches can inform cancer control surveillance and intervention targets such
as obesity and HPV vaccination, among others. There is an opportunity to
leverage this rapidly evolving, participative media environment to inform
cancer communication surveillance, and to develop and test frameworks and
models to explore the mechanisms by which the new communication landscape
affects individual behavior and population health, as well as to explore
opportunities for leveraging innovative approaches and technologies in
intervention research.

As a primary funder of cancer-related behavioral research, NCI's
Division of Cancer Control and Population Sciences is seeking opportunities to
support the use and integration of non-traditional data collection and analytic
techniques in cancer communication science. These methods tend to be more
nimble and able to accommodate the changing communication landscape; they may
include, but are not limited to social media data mining, Natural Language
Processing (NLP) techniques, online social network analysis, crowdsourcing
research tools (e.g., mTurk), online search data, Ecological Momentary
Assessment, neuroscience and biobehavioral approaches to communication, and
geographic information systems, among others. These methods, adopted from a
diverse set of behavioral, cognitive, and social science disciplines, will
complement traditional approaches to assessing exposure to cancer information,
media effects, and intervention effects.

Research Objectives

This FOA is intended to encourage research projects in three
distinct domains related to cancer communication: 1) utility of new
communication surveillance approaches, 2) development and testing of larger
scale interventions using innovative methods and designs, and 3) development
and testing of new cancer communication conceptual models. Applicants should
apply communication science approaches to the investigation of behavioral
targets related to cancer prevention and control. These include but are not
limited to effectively communicating risks for cancer; affecting positive
behavior change relevant to cancer control (e.g., tobacco use, diet, physical
activity, alcohol use, sun protection); enabling effective utilization of
cancer treatment and navigation of the health care system; offering
informational, social, and psychological support for decision making in cancer
screening and treatment; and maximizing quality of life for survivors and their
caregivers, including the utilization of palliative care – all leveraging the
participatory nature of new media. Multi-level approaches are encouraged.
Intervention studies should consider applicability across multiple contexts
(e.g., health systems, family- or community-based settings, or virtual/online
communities). Applications that target low socioeconomic status and/or rural
populations are encouraged.

Examples
of Applications and Research Questions

I.Cancer
Communication Surveillance Approaches:

Develop communication surveillance methods to track and
identify communication inequalities and examine modes of communication used by
individuals, communities, and population subgroups; monitor public opinion,
sentiment, social norms, and reported behaviors related to cancer control;
evaluate media effects on individual or population health.

When and under what conditions (e.g., policy or guidelines
changes) do people access and engage in online discussions about topics
relevant to cancer?

How can data mining approaches be leveraged to monitor public
sentiment and identify cancer-related health threats and communication gaps?

What is the impact of online user-generated content on
individual- and population-level beliefs, attitudes, behaviors related to cancer
control?

II.Innovative
Methodologies for Cancer Communication Interventions:

Develop novel designs to test participative communication
strategies in cancer prevention and control; examine the effectiveness of these
strategies at the individual or population level, as well as potential network
effects.

How can the participative communication landscape be leveraged to
improve cancer communication intervention design (e.g., social media-based
interventions) and measurement of outcomes (e.g., risk perception, decision
making, and attitudes)?

How can participative media be leveraged to complement
traditional media channels to help address communication inequalities and
cancer health disparities?

III.Cancer
Communication Conceptual Models:

Develop and test new communication conceptual models that
leverage the opportunities enabled by the participative communication
environment, and identify the pathways by which participative communication
affects cancer prevention and control outcomes.

How can innovative research methodologies be used to create,
adapt, and test communication and health behavior theories, frameworks, and
models that account for the independent, mediating, or moderating effects of
the participative media environment on cancer-related behavioral domains?

How can public participation in the creation of content,
including engagement in the form of commentary, “liking,” and sharing, be
optimally operationalized and measured?

To what extent does public participation and user-generated
content affect information processing and other pathways between information
exposure and behavioral outcomes?

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to
apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.

Required
Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually.
The renewal process may require as much time as the initial registration. SAM
registration includes the assignment of a Commercial and Government Entity
(CAGE) Code for domestic organizations which have not already been assigned a
CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must obtain the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

Appendix:
Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424
(R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission. When a
submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date and time. If a Changed/Corrected application is submitted after the
deadline, the application will be considered late. Applications that miss the
due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the SF424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant will
not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application
and follow the Policy on the Acceptance for Review of Unsolicited Applications
that Request $500,000 or More in Direct Costs as described in the SF424
(R&R) Application Guide.

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an
important problem or a critical barrier to progress in the field? Is there a
strong scientific premise for the project? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the project? If Early Stage Investigators
or
those in the early stages
of independent careers, do they
have appropriate experience and training? If established, have they
demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation,
or interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches
or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Have the investigators presented strategies to
ensure a robust and unbiased approach, as appropriate for the work proposed? Are
potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed? Have
the investigators presented adequate plans to address relevant biological variables,
such as sex, for studies in vertebrate animals or human subjects?

If the project involves human
subjects and/or NIH-defined clinical research, are the plans to address 1) the
protection of human subjects from research risks, and 2) inclusion (or exclusion)
of individuals on the basis of sex/gender, race, and ethnicity, as well as the
inclusion or exclusion of children, justified in terms of the scientific goals
and research strategy proposed?

Environment

Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.

Inclusion of Women, Minorities,
and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.

Vertebrate Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures
involving animals, including species, strains, ages, sex, and total number to
be used; (2) justifications for the use of animals versus alternative models
and for the appropriateness of the species proposed; (3) interventions to
minimize discomfort, distress, pain and injury; and (4) justification for
euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia
of Animals. Reviewers will assess the use of chimpanzees as they would any
other application proposing the use of vertebrate animals. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmissions

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will
consider the appropriateness of the proposed expansion of the scope of the
project. If the Revision application relates to a specific line of
investigation presented in the original application that was not recommended
for approval by the committee, then the committee will consider whether the
responses to comments from the previous scientific review group are adequate
and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key biological and/or chemical resources,
reviewers will comment on the brief plans proposed for identifying and ensuring
the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the Center for
Scientific Review (CSR), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.